A Study To Investigate The Effect Of Food On The Pharmacokinetics Of PH-797804

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Randomized, Open-Label, Single Dose, 2-Cohort Crossover Study To Determine The Effect Of Food On The Pharmacokinetics Of Orally Administered PH-797804 In Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01479647
• Other study ID #: A6631034
• Status: Completed
• Phase: Phase 1
• First received: November 22, 2011
• Last updated: February 25, 2012
• Start date: December 2011
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of food on the time course of PH-797804 concentration in the blood following dosing by oral immediate release tablet formulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 21 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs).

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

• A positive urine drug screen.

• History of regular alcohol consumption exceeding 21 drinks/week for males.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• PH-797804
Tablet, 1 mg, single dose
• PH-797804
Tablet, 1 mg, single dose
• PH-797804
Tablet, 10 mg, single dose
• PH-797804
Tablet, 10 mg, single dose
• PH-797804
Tablet, 24 mg, single dose

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: peak plasma concentration		0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose	No
Primary	Pharmacokinetics: time to peak plasma concentration		0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose	No
Primary	Pharmacokinetics: area under the plasma concentration-time curve		0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose	No
Primary	Pharmacokinetics: terminal plasma half-life		0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose	No

External Links

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